Docusate Sodium 12.5mg/5mL Oral Solution

Always use this medicine exactly as described in this leaflet or as the patient’s doctor or pharmacist have told you.

• Keep this leaflet. You may need to read it again.
• Ask the patient’s pharmacist if you need more information or advice.
• If you get any side effects, talk to the patient’s doctor or pharmacist.
• This includes any possible side effects not listed in this leaflet. See section 4.
• You must talk to a doctor if the patient does not feel better or if the patient feels worse after a few days.

1. What Docusate sodium oral solution is and what it is used for
2. What you need to know before the patient takes Docusate sodium oral solution
3. How to take Docusate sodium oral solution
4. Possible side effects
5. How to store Docusate sodium oral solution
6. Contents of the pack and other information

• if the patient is allergic to docusate sodium or any of the other ingredients of this medicine (listed in section 6).
• if the patient is suffering from stomach pains or an obstruction in the gut.
• if the patient is feeling sick or has been sick in the last 24 hours.

Talk to the patient’s doctor or pharmacist before the patient starts taking Docusate sodium oral solution

• Docusate sodium oral solution should not be given to infants under the age of 6 months.
• Prolonged use can cause the gut to become lazy and not work properly.

Tell the patient’s doctor or pharmacist if the patient is taking, have recently taken or might take any other medicines.

Docusate sodium oral solution should not be taken if you are already taking mineral oil. Patients already taking other laxatives called anthraquinone laxative such as senna, will need to take reduced doses as Docusate sodium oral solution increases their effects.

Docusate sodium oral solution can be taken with food and drink.

Do not use Docusate sodium oral solution if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Docusate sodium oral solution contains methyl parahydroxybenzoate and propyl parahydroxybenzoate.

This medicine contains 5mg of methyl p-hydroxybenzoate and 2.5 mg of propyl p-hydroxybenzoate in each dose (5ml). May cause allergic reactions (possibly delayed).

Docusate sodium oral solution contains sorbitol.

This medicine contains 840mg of sorbitol in each dose (5ml). Sorbitol is a source of fructose. If the patient’s doctor has told you that the patient has an intolerance to some sugars or if the patient has been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to a doctor before the patient takes this medicine. Sorbitol may cause gastrointestinal discomfort and mild laxative effect.

Sodium content.

This medicinal product contains 29.7mg sodium (main component of cooking/table salt) per 30ml (maximum daily dose).This is equivalent to 1.5% of the recommended maximum daily intake of sodium for an adult.

Docusate sodium oral solution contains propylene glycol.

This medicine contains 3.7 mg propylene glycol in each 5ml dose. If your baby is less than 4 weeks old, talk to your doctor or pharmacist before giving them this medicine, in particular if the baby is given other medicines that contain propylene glycol or alcohol.

The recommended dose for infants aged over 6 months is 5ml three times a day.

The recommended dose for children aged 2-12 years is 5ml to 10 ml three times a day.

Dilute the medicine in a glass of flavoured drink such as fruit juice or milk and give to the patient to drink within 30 minutes of preparation. This medicine should not be given to infants under the age of 6 months. Reduce the dose as the condition improves.

When taken before a stomach X-ray the dose is 30ml, as a single dose. Docusate sodium may cause an unpleasant aftertaste or burning sensation. This may be minimised by drinking plenty after taking the solution.

If the patient takes more Docusate sodium oral solution than they should, the patient should drink lots of water.

The nearest hospital casualty department should be contacted or the patient’s doctor must be informed immediately.

Give the patient their usual dose and then continue the normal course of treatment. Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this product, ask the doctor or pharmacist.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is docusate sodium (12.5mg/5ml)
• The other ingredients are methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium dihydrogen phosphate dihydrate (E339i), disodium hydrogen phosphate dihydrate (E339ii), glycerol (E422), kollidon 90F (E1201), sorbitol 70% (E420), sucralose (E955), citric acid (E330), strawberry flavour (contains propylene glycol) and purified water

Docusate sodium oral solution is a clear, colorless to pale yellow, viscous solution with strawberry odor available in an amber glass bottle of 300ml with a plastic screw cap. It comes with a dosing cup with 2.5 / 5 / 10 / 15 ml graduations.